TempoLok NE Cement 2x5ml syringe, 20 mixing tips

GUDID 00841549100468

Temporary cement for attaching all kinds of temporaries, e.g. temporary crowns and bridges and inlays. They can also be used as a securely sealing protective cover for preparations to be restored later. The TempoLok™ NE includes: 2- 5ml Syringes and 20 Mixing Tips of non-eugenol, zinc oxide cement.

STERNGOLD DENTAL LLC

Zinc oxide eugenol dental cement Zinc oxide eugenol dental cement Zinc oxide eugenol dental cement Zinc oxide eugenol dental cement Zinc oxide eugenol dental cement Zinc oxide eugenol dental cement Zinc oxide eugenol dental cement Zinc oxide eugenol dental cement Zinc oxide eugenol dental cement Zinc oxide eugenol dental cement Zinc oxide eugenol dental cement Zinc oxide eugenol dental cement Zinc oxide eugenol dental cement Zinc oxide eugenol dental cement Zinc oxide eugenol dental cement Zinc oxide eugenol dental cement Zinc oxide eugenol dental cement Zinc oxide eugenol dental cement
Primary Device ID00841549100468
NIH Device Record Key8350e3d3-3e9e-4565-b8c5-4d05460d201a
Commercial Distribution StatusIn Commercial Distribution
Brand NameTempoLok NE Cement 2x5ml syringe, 20 mixing tips
Version Model Number220265
Company DUNS124763728
Company NameSTERNGOLD DENTAL LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone508-226-5660
Emaillaura.geige@sterngold.com
Phone508-226-5660
Emaillaura.geige@sterngold.com
Phone508-226-5660
Emaillaura.geige@sterngold.com
Phone508-226-5660
Emaillaura.geige@sterngold.com
Phone508-226-5660
Emaillaura.geige@sterngold.com
Phone508-226-5660
Emaillaura.geige@sterngold.com
Phone508-226-5660
Emaillaura.geige@sterngold.com
Phone508-226-5660
Emaillaura.geige@sterngold.com
Phone508-226-5660
Emaillaura.geige@sterngold.com
Phone508-226-5660
Emaillaura.geige@sterngold.com
Phone508-226-5660
Emaillaura.geige@sterngold.com
Phone508-226-5660
Emaillaura.geige@sterngold.com
Phone508-226-5660
Emaillaura.geige@sterngold.com
Phone508-226-5660
Emaillaura.geige@sterngold.com
Phone508-226-5660
Emaillaura.geige@sterngold.com
Phone508-226-5660
Emaillaura.geige@sterngold.com
Phone508-226-5660
Emaillaura.geige@sterngold.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841549100468 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EMACement, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-09
Device Publish Date2017-02-24

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